Chapter 2

Concept of Validation


Validation is first given by the US in 1978. According to the Food and Drug Administration, the validation is defined as the documented evidence for providing the assurance that the product is meeting the predetermined specifications. Validation ensures the product quality. The purpose of the validation is as follows:

  • To list out the tests to be carried out
  • The frequency of the testing
  • The acceptance criteria

The validation is continuous evolving process. The validation is carried out in the following way:

  • Before buying of the equipment
  • Before the facility planning for the building
  • Chemical development stage
  • Developing the process
  • Conducting the clinical studies

There are mainly ...

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